WO2016121244A1 - Cathéter à ballonnet - Google Patents

Cathéter à ballonnet Download PDF

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Publication number
WO2016121244A1
WO2016121244A1 PCT/JP2015/084749 JP2015084749W WO2016121244A1 WO 2016121244 A1 WO2016121244 A1 WO 2016121244A1 JP 2015084749 W JP2015084749 W JP 2015084749W WO 2016121244 A1 WO2016121244 A1 WO 2016121244A1
Authority
WO
WIPO (PCT)
Prior art keywords
balloon
inner tube
connecting portion
catheter
end side
Prior art date
Application number
PCT/JP2015/084749
Other languages
English (en)
Japanese (ja)
Inventor
土井裕太
Original Assignee
テルモ株式会社
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by テルモ株式会社 filed Critical テルモ株式会社
Priority to JP2016571804A priority Critical patent/JP6749847B2/ja
Publication of WO2016121244A1 publication Critical patent/WO2016121244A1/fr
Priority to US15/653,078 priority patent/US10617856B2/en

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Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M25/00—Catheters; Hollow probes
    • A61M25/10—Balloon catheters
    • A61M25/1006—Balloons formed between concentric tubes
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M29/00—Dilators with or without means for introducing media, e.g. remedies
    • A61M29/02—Dilators made of swellable material
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M39/00—Tubes, tube connectors, tube couplings, valves, access sites or the like, specially adapted for medical use
    • A61M39/02—Access sites
    • A61M39/06—Haemostasis valves, i.e. gaskets sealing around a needle, catheter or the like, closing on removal thereof
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M25/00—Catheters; Hollow probes
    • A61M25/10—Balloon catheters
    • A61M25/1002—Balloon catheters characterised by balloon shape
    • A61M2025/1004—Balloons with folds, e.g. folded or multifolded
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M25/00—Catheters; Hollow probes
    • A61M25/10—Balloon catheters
    • A61M2025/1043—Balloon catheters with special features or adapted for special applications
    • A61M2025/1084—Balloon catheters with special features or adapted for special applications having features for increasing the shape stability, the reproducibility or for limiting expansion, e.g. containments, wrapped around fibres, yarns or strands
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M2205/00—General characteristics of the apparatus
    • A61M2205/02—General characteristics of the apparatus characterised by a particular materials
    • A61M2205/0216—Materials providing elastic properties, e.g. for facilitating deformation and avoid breaking
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M25/00—Catheters; Hollow probes
    • A61M25/10—Balloon catheters
    • A61M25/1018—Balloon inflating or inflation-control devices
    • A61M25/10184—Means for controlling or monitoring inflation or deflation

Definitions

  • the present invention relates to a balloon catheter having a balloon at the tip.
  • Balloon catheters are widely used to improve lesions (stenosis) occurring in living body lumens.
  • a balloon catheter usually includes a long catheter body and a balloon that is provided on the distal end side of the catheter body and can be expanded in the radial direction.
  • the lesion can be expanded by expanding after reaching the target location via the body.
  • the catheter body has a hollow outer tube and an inner tube, and the inner tube is disposed inside the hollow of the outer tube.
  • the distal end of the outer tube is fixed to the proximal end of the balloon, and the hollow interior of the outer tube forms an expansion lumen that communicates with the interior of the balloon.
  • the balloon can be expanded by injecting an expansion fluid through the expansion lumen.
  • the distal end portion of the inner tube is fixed to the distal end side of the balloon, and the hollow interior of the inner tube forms a guide wire lumen through which the guide wire can be inserted.
  • ⁇ Treatment with a balloon catheter is performed according to the following procedure. First, a guide wire is inserted into the living body lumen and passed through the lesion. Next, a balloon catheter is inserted along the guide wire, the balloon is delivered to the lesion, and the balloon that has reached the lesion is expanded to perform treatment. Thereafter, the balloon is deflated and the balloon catheter is removed from the body.
  • the balloon can be expanded and then deflated and then expanded again at the same location, or the balloon can be expanded and then deflated and then moved to another lesion. In some cases, a procedure such as re-expansion is performed.
  • the balloon catheter Since the balloon catheter is inserted into a thin living body lumen, moved, and taken out, the balloon catheter must have good passage through the living body lumen. In a balloon catheter, since the diameter of the balloon portion is large, it is required that the balloon be as tight as possible. For this reason, when deflated, the balloon is folded so as to have a contact portion that contacts the inner tube and a plurality of blade portions that protrude radially from the contact portion.
  • the balloon When the balloon is expanded and then contracted, the balloon returns to the original shape having the contact portion and the blade portion.
  • the shape at the time of contraction may collapse.
  • the original shape at the time of contraction has three blade portions arranged so as to form an angle of 120 degrees in the circumferential direction, and the contact portion is between each blade portion.
  • the shape of the contact portion cannot be restored to the original, and the adjacent blade portions are joined to each other so that the balloon has a shape having two blade portions. is there.
  • the number of blade portions decreases, the protruding length of one blade portion increases.
  • the shape varies because the number of blade portions is different from the original number. For this reason, the outer diameter of a balloon part becomes large and the passage property of a balloon catheter falls.
  • the balloon catheter is required to have a good relap property that surely returns to its original shape when the balloon is expanded and contracted. Therefore, for example, in Patent Document 1, a metallic external member having a band and a finger is attached to the balloon from the outside, and the finger is disposed at the position of the contact portion. A technique in which the contact portion is pressed so as to return to the original position is disclosed.
  • the present invention has been made to solve the above-described problems, and an object of the present invention is to provide a balloon catheter having good balloon rewrap without attaching an external member from the outside of the balloon.
  • a catheter according to the present invention that achieves the above object has a long catheter main body and an expandable / contractible balloon provided on the distal end side of the catheter main body, and the catheter main body is a hollow outer tube. And a hollow inner tube disposed inside the outer tube, wherein the balloon is in a contracted state, and has a contact portion that comes into contact with the inner tube, and a blade portion that projects radially from the contact portion.
  • the balloon has a connecting portion connected to the catheter main body at the contact portion.
  • the catheter configured as described above reliably returns to its original shape when contracted because the contact portion is connected to the inner tube by the connecting portion even when the balloon repeats expansion and contraction a plurality of times. Can do. That is, the rewrapability of the balloon can be improved without attaching an external member from the outside of the balloon.
  • the balloon is fixed to the outer tube at the proximal end, the distal end is fixed to the inner tube, and the connecting portion is formed to be fixed to the outer tube or the peripheral surface of the inner tube.
  • a connection part can be formed only by making it adhere to the surrounding surface of an inner pipe, and can manufacture easily.
  • the balloon has an enlarged diameter portion whose diameter increases from the proximal end side toward the distal end side, the same diameter portion that is continuous with the enlarged diameter portion and has substantially the same diameter along the axial direction, and the proximal end side that is continuous with the same diameter portion. If the diameter of the connecting portion does not exist in the same diameter portion, the connecting portion has the same diameter as the effective portion at the time of treatment. It is possible to minimize the influence of.
  • the connecting portion balloon is formed.
  • the connection strength between the inner tube and the inner tube can be increased, and the connection portion can be prevented from peeling (breaking) when the balloon is expanded.
  • the connecting portion has a small fixing area if the balloon and the inner tube are fixed in a dotted manner at a position closer to the center of the balloon than the fixing portion where the balloon is fixed to the outer tube or the inner tube. Therefore, manufacturing can be facilitated.
  • the connecting portion may prevent stress from concentrating on the end portion on the central side of the connecting portion. It is possible to prevent peeling (breaking) of the connecting portion.
  • the balloon is fixed to the outer tube on the base end side, fixed to the inner tube on the distal end side, and the connecting portion is formed of a stretchable material that suspends between the balloon and the outer tube or the inner tube.
  • the connecting portion can be provided in a wide range of the balloon including the same diameter portion.
  • the inner tube has an outer peripheral member on at least a part of the outer periphery inside the balloon, the connecting portion connects the balloon and the outer peripheral member, and the outer peripheral member is within a range where at least the connecting portion is connected in the axial direction. If the inner tube is not restrained by the peripheral surface, the inner tube can be prevented from being pulled outward by the connecting portion when the balloon is expanded, and the guide wire slides due to the extension of the inner tube. It can prevent the deterioration of mobility.
  • the inner tube has a reinforcing portion with increased strength in a range that is connected at least in the axial direction by the connecting portion, the inner tube is pulled outward by the connecting portion when the balloon is expanded. Further, it is possible to prevent deterioration of the slidability of the guide wire due to a decrease in strength of the portion.
  • the side of the balloon catheter 10 to be inserted into the living body lumen is referred to as “tip” or “tip side”
  • the proximal side for operation is referred to as “base end” or “base end side”.
  • the balloon catheter 10 includes a long hollow catheter body 11, a balloon 30 provided at the distal end of the catheter body 11, and a hub fixed to the proximal end of the catheter body 11. 20.
  • the catheter body 11 includes an outer tube 14 that is a hollow tubular body, and an inner tube 15 that is disposed inside the outer tube 14.
  • An expansion lumen 16 through which an expansion fluid for expanding the balloon 30 flows is formed between the outer tube 14 and the inner tube 15, and a guide wire (not shown) is inserted inside the inner tube 15.
  • a wire lumen 17 is formed.
  • the outer tube 14 and the inner tube 15 are preferably formed of a material having a certain degree of flexibility.
  • a material having a certain degree of flexibility examples include polyethylene, polypropylene, polybutene, ethylene-propylene copolymer, ethylene-acetic acid.
  • Polyolefin such as vinyl copolymer, ionomer, or a mixture of two or more thereof, soft polyvinyl chloride resin, polyamide, polyamide elastomer, polyester, polyester elastomer, polyurethane, polytetrafluoroethylene and other fluororesin, silicone rubber, latex Rubber etc. can be used.
  • the balloon 30 is formed of a flexible material like the outer tube 14 and the inner tube 15. Since the balloon 30 forms the distal end portion of the catheter main body 11, a highly flexible material is selected.
  • the balloon 30 is in a deflated state.
  • the balloon 30 is schematically shown in a deflated state and an expanded state.
  • the distal end side of the balloon 30 is fixed to the inner tube 15, and the proximal end side is fixed to the outer tube 14, and the inside of the balloon 30 communicates with the expansion lumen 16. Thereby, the balloon 30 can be expanded by injecting the expansion fluid through the expansion lumen 16.
  • the expansion fluid may be a gas or a liquid.
  • a gas such as helium gas, CO 2 gas, or O 2 gas, or a liquid such as physiological saline or contrast medium can be used.
  • the hub 20 communicates with the expansion lumen 16 formed between the outer tube 14 and the inner tube 15, and functions as a port for allowing the expansion fluid to flow in and out, and the guide wire lumen 17 communicates with the first opening 21. 2 openings 22.
  • the second opening 22 is provided with a hemostasis valve 23 that suppresses blood outflow while allowing the guide wire to be inserted.
  • the base end side end portion of the balloon 30 is a base end side fixing portion 31 fused to the peripheral surface of the outer tube 14.
  • the balloon 30 has an enlarged diameter portion 33 whose outer diameter increases from the proximal end fixing portion 31 toward the distal end side, and an identical diameter portion 34 that is continuous with the enlarged diameter portion 33 and has substantially the same diameter in the axial direction of the catheter body 11. And a reduced-diameter portion 35 that is continuous with the same-diameter portion 34 and has an outer diameter that decreases toward the distal end side.
  • the distal end side end portion of the balloon 30 is a distal end side fixing portion 32 fused to the peripheral surface of the inner tube 15.
  • the balloon 30 at the time of contraction actually has a shape as described below.
  • the deflated balloon 30 is folded around the inner tube 15.
  • the folded balloon 30 has a contact portion 36 that contacts the inner tube 15 along the circumferential direction of the inner tube 15 and a blade portion 37 that protrudes in the radial direction from the contact portion 36.
  • the contact portion 36 is in close contact with the peripheral surface of the inner tube 15.
  • wing part 37 is extended so that it may curve to the circumferential direction while going to radial direction outward from the contact part 36.
  • FIG. In the state where the balloon 30 is folded, three blade portions 37 are formed in the circumferential direction, and three contact portions 36 between the blade portions 37 are also formed in the circumferential direction.
  • the three blade portions 37 are all curved in the same direction in the circumferential direction.
  • the reduced diameter part 35 of the balloon 30 has a connecting part 40 connected to the peripheral surface of the inner tube 15.
  • the connecting portion 40 is formed by connecting the contact portions 36 at three locations in the circumferential direction to the inner tube 15. In FIG. 3, the connecting portion 40 is indicated by a thick line for easy understanding. In this example, the connecting portion 40 is formed by fusion of the balloon 30 and the inner tube 15.
  • the region where the balloon 30 is fused to the catheter body 11 is indicated by hatching.
  • the balloon 30 is fused to the outer tube 14 in the circumferential direction at the proximal end fixing portion 31, and is fused to the inner tube 15 in the circumferential direction at the distal end fixing portion 32.
  • a region that becomes the contact portion 36 in the circumferential direction is fused to the inner tube 15 to form a connecting portion 40.
  • the connecting portion 40 is formed in a linear shape continuous from the distal end side fixing portion 32 toward the proximal end side, and the end portion extends to the proximal end portion of the reduced diameter portion 35. Further, the base end side end portion of the connecting portion 40 is formed to have a smooth curved shape, specifically, a substantially semicircular shape.
  • the balloon 30 having the connecting portion 40 expands when an expansion fluid is fed and pressurized, and has a shape as shown in FIG.
  • the contact portion 36 is fixed to the inner tube 15 by the connecting portion 40, and therefore remains in close contact with the inner tube 15.
  • wing part 37 expand
  • the same diameter part 34 expands in cross-sectional substantially circular shape, and the deformation
  • the balloon 30 contracts when the pressure is reduced from the pressurized state in FIG. 5 and returns to the contracted state in FIG. 3 again.
  • the contact portion 36 of the reduced diameter portion 35 is in close contact with the inner tube 15 by the connecting portion 40, the contact on the proximal end side with respect to the reduced diameter portion 35 of the balloon 30 is also made at three places in the circumferential direction. It becomes easy for the part 36 to return to the original shape. Accordingly, the three blade portions 37 in the circumferential direction also easily return to the original shape. Even when the balloon 30 repeats expansion and contraction a plurality of times, the contact portion 36 of the reduced diameter portion 35 is always in close contact with the inner tube 15, so that it can surely return to its original shape. That is, the rewrapability of the balloon 30 can be improved.
  • the end of the base end side of the connecting portion 40 extends to the base end side end of the reduced diameter portion 35, so that the connecting portion 40 is closer to the base end side than the same diameter portion 34 of the balloon 30.
  • the effect which returns to the original shape at the time of contraction can be enlarged.
  • the connecting portion 40 since the end portion on the proximal end side of the connecting portion 40 is formed in a smooth curved shape, when the balloon 30 is pressurized and expanded, stress is applied to the end portion on the proximal end side of the connecting portion 40. As a result, the connecting portion 40 can be prevented from breaking.
  • connection part 41 of a 1st modification is demonstrated.
  • the connecting portion 41 of the first modified example is formed not only in the reduced diameter portion 35 of the balloon 30 but also in the enlarged diameter portion 33.
  • the connecting portion 41 on the reduced diameter portion 35 side has the same configuration as the connecting portion 40 in FIG.
  • the connecting portion 41 on the enlarged diameter portion 33 side is formed in the region of the contact portion 36 of the balloon 30 in the circumferential direction, and extends linearly from the proximal end side fixing portion 31 toward the distal end side in the axial direction.
  • the end portion on the distal end side extends to the end portion on the distal end side of the enlarged diameter portion 33.
  • connection portion 41 not only on the reduced diameter portion 35 side but also on the enlarged diameter portion 33 side, it is possible to easily return to the original shape when the balloon 30 is deflated.
  • a connection part is provided also on the diameter expansion part 33 side. Can be provided.
  • a connecting portion may be provided only on the diameter-expanded portion 33 side.
  • the connecting portion 41 on the side of the enlarged diameter portion 33 connects the balloon 30 and the inner tube 15, but extends the outer tube 14 to the inside of the balloon 30 and connects the outer tube 14 and the balloon 30. May be.
  • connection part 42 of the second modification will be described.
  • the connecting portion 42 of this example is formed in the region of the contact portion 36 of the balloon 30 in the circumferential direction, and in the axial direction, the connecting portion 42 is a line from the distal end side fixing portion 32 toward the proximal end side.
  • the end portion on the base end side extends to an intermediate position in the axial direction of the reduced diameter portion 35. That is, the connecting portion 42 of this example is shorter in the axial direction than the connecting portion 40 of FIG.
  • the axial length of the connecting portion 42 can be set arbitrarily.
  • the distal end position of the connecting portion 42 is located on the distal end side in the reduced diameter portion 35, the force to return to the original shape when the balloon 30 contracts is weakened, but the balloon 30 and the inner tube 15 are connected at the connecting portion 42. It is possible to prevent deformation of the balloon shape at the time of expansion, particularly deformation at the same diameter portion due to being connected.
  • connection part 43 of the 3rd modification is formed in two places in the range of the reduced diameter part 35 at the point in the axial direction.
  • the position in the circumferential direction of the connecting portion 43 is an area of the contact portion 36 of the balloon 30.
  • the connection part 43 does not need to be continuous linear.
  • the connection part 44 may be only one place.
  • the connecting portion 45 of the fifth modification extends from the distal end side fixing portion 32 toward the proximal end side, and the circumferential width of the connecting portion 42 extends from the distal end side toward the proximal end side.
  • the connection portion 42 as a whole has a substantially triangular shape.
  • the connecting portion 46 of the sixth modification extends from the distal end side fixing portion 32 toward the proximal end side, and the circumferential width of the connecting portion 46 is larger at the distal end side and closer to the proximal end side. It is small and is formed so that the width changes at an intermediate position in the axial direction. In this way, the shape of the connecting portion can be set variously.
  • the connecting portion 47 of the seventh modification will be described.
  • the connecting portion 47 of this example is provided so as to suspend the inner tube 15 and the balloon 30.
  • the connecting portion 47 is made of a stretchable material.
  • the connecting portion 47 is formed in the range of the contact portion 36 of the balloon 30 in the circumferential direction and in the range of the reduced diameter portion 35 of the balloon 30 in the axial direction.
  • FIG. 12 shows a state where the balloon 30 is expanded, and when the balloon 30 is expanded, the stretchable connecting portion 47 expands together with the balloon 30.
  • the connecting portion 47 generates a repulsive force in the contracting direction with respect to the expansion, but it is necessary to form the connecting portion 47 to such an extent that the repulsive force does not greatly affect the shape of the same-diameter portion 34 when the balloon 30 is expanded. There is.
  • the contact portion 36 can be reliably returned to the original shape by the urging force of the connecting portion 47 in the contraction direction.
  • the material of the connecting portion 47 having elasticity for example, rubber or thermoplastic elastomer can be used.
  • the same effect can be obtained not only by directly fixing the balloon 30 and the catheter main body 11 but also by forming the connecting portion 47 with a stretchable material. Further, in this case, by appropriately setting the elasticity of the connecting portion 47, it is possible to provide not only the reduced diameter portion 35 and the enlarged diameter portion 33 but also the range of the same diameter portion 34 in the axial direction. Further, the shape and arrangement of the connecting portion 47 formed of a stretchable material may be configured as in the examples of FIGS. 4 and 6 to 11 in which the balloon 30 and the catheter body 11 are directly fixed.
  • an outer peripheral member 18 is provided on the inner tube 15.
  • the outer peripheral member 18 is formed in a tubular shape having a diameter that is slightly larger than the inner tube 15.
  • the distal end side end portion of the outer peripheral member 18 is fused to the inner tube 15 together with the distal end side fixing portion 32 of the balloon 30.
  • the outer peripheral member 18 is not restrained by the peripheral surface of the inner tube 15 except for the end portion on the front end side.
  • the connecting portion 50 connects the balloon 30 and the outer peripheral member 18. Since the connecting portion 50 extends toward the base end side from the distal end side fixing portion 32 of the balloon 30, the portion connected to the connecting portion 50 of the outer peripheral member 18 is constrained by the peripheral surface of the inner tube 15. Absent. For this reason, when the balloon 50 is expanded, the outer peripheral member 18 is pulled radially outward, but the inner tube 15 can be prevented from being pulled by the balloon 50.
  • the outer peripheral member 18 is provided outside the inner tube 15, and such a problem can be solved by connecting the outer peripheral member 18 and the balloon 30 with the connecting portion 50.
  • the connecting portion 51 is formed in a dot shape
  • the outer peripheral member 19 is formed in a short tubular shape including a range where the connecting portion 51 is formed in the axial direction.
  • the outer peripheral member 19 is not fused to the inner tube 15 and is not restrained by the peripheral surface of the inner tube 15.
  • the connection part 51 is short in an axial direction
  • tube 15 can be suppressed to the minimum by providing the outer peripheral member 19 only in the part corresponding to it.
  • the shape of the outer peripheral member is not limited to a tubular shape, and may be any shape that exists on at least a part of the outer periphery of the inner tube 15.
  • a part of the inner tube 15 is a reinforcing part 15 a having a higher strength than the other parts.
  • the connecting portion 52 is formed by connecting the reinforcing portion 15 a and the balloon 30.
  • the inner tube 15 has a reinforcing portion 15a in a range where the connecting portion 52 is formed in the axial direction.
  • the reinforcing portion 15a can be formed by increasing the thickness of the portion when the inner tube 15 is manufactured.
  • the inner tube 15 having a uniform thickness is manufactured, and a part of the inner tube 15 is covered with another tubular member from above, and the reinforcing portion 15a is integrated by fusing or bonding them together. It may be formed.
  • the connecting portion 53 is formed in a dot shape, and the reinforcing portion 15 b is formed only in a portion corresponding to the connecting portion 53.
  • the expansion of the inner tube can be suppressed when the balloon 30 is expanded and the inner tube 15 is pulled radially outward by the connecting portion.
  • the balloon catheter 10 includes the long catheter main body 11 and the expandable / contractible balloon 30 provided on the distal end side of the catheter main body 11. It has a hollow outer tube 14 and a hollow inner tube 15 disposed inside the outer tube, and the balloon 30 is in a contracted state, and a contact portion 36 that contacts the inner tube 15 and a radial direction from the contact portion 36
  • the balloon 30 has a connecting portion 40 connected to the catheter main body 11 at the contact portion 36. For this reason, even when the balloon 30 is repeatedly expanded and contracted a plurality of times, the contact portion 36 is connected to the inner tube 15 by the connecting portion 40, so that it can surely return to its original shape when contracted. . In other words, the rewrapability of the balloon 30 can be improved without attaching an external member from the outside of the balloon 30.
  • the catheter body 11 has the balloon 30 fixed to the outer tube 14 at the proximal end and fixed to the inner tube 15 at the distal end, and the connecting portion 40 is fixed to the outer surface of the outer tube 14 or the inner tube 15. If formed, the connecting portion 40 can be formed simply by fixing the balloon 30 to the peripheral surface of the outer tube 14 or the inner tube 15, and manufacturing can be facilitated.
  • the balloon 30 has a diameter-enlarged portion 33 having a diameter that increases from the proximal end side toward the distal end side, a diameter-equalized portion 34 that is continuous with the diameter-expanded portion 33 and has substantially the same diameter along the axial direction, 34 and a reduced diameter portion 35 that decreases in diameter from the proximal end side toward the distal end side, and the connecting portion 40 is an effective portion at the time of treatment if it does not exist in the same diameter portion 34.
  • the shape of the same diameter portion 34 can be prevented from being influenced as much as possible by the connecting portion 40.
  • the connecting portion 40 has the balloon 30 and the inner tube 15 fixed linearly from the fixing portions 31 and 32 where the balloon 30 is fixed to the outer tube 14 or the inner tube 15 toward the center of the balloon 30. If formed, the connection strength between the balloon 30 and the inner tube 15 by the connecting portion 40 can be increased, and the connecting portion 40 can be prevented from peeling (breaking) when the balloon 30 is expanded.
  • the connecting portion 42 has the balloon 30 and the inner tube 15 fixed in a dotted manner at a position closer to the center of the balloon 30 than the fixing portions 31 and 32 to which the balloon 30 is fixed to the outer tube 14 or the inner tube 15. If formed, the fixing area may be small, and the manufacturing can be facilitated.
  • the end portion on the center side of the balloon 30 is formed in a smooth curved shape, the stress is concentrated on the end portion on the center side of the connection portion 40 when the balloon 30 is expanded. It is possible to prevent the connection portion 40 from peeling off (breaking).
  • the catheter body 11 has a hollow outer tube 14 and a hollow inner tube 15 disposed inside the outer tube 14, and the balloon 30 has a proximal end fixed to the outer tube 14 and a distal end. If the side is fixed to the inner tube 15 and the connecting portion 47 is formed of a stretchable material that suspends between the balloon 30 and the outer tube 14 or the inner tube 15, the elasticity of the connecting portion 47 is appropriately set. By setting, the connecting portion 47 can be provided in a wide range of the balloon 30 including the same-diameter portion 34.
  • the inner tube 15 has an outer peripheral member 18 on at least a part of the outer periphery inside the balloon 30, the connecting portion 50 connects the balloon 30 and the outer peripheral member 18, and the outer peripheral member 18 is at least in the axial direction.
  • the inner tube 15 is prevented from being pulled outward by the connecting portion 50 when the balloon 30 is expanded as long as the connection portion 50 is not restrained by the peripheral surface of the inner tube 15. It is possible to prevent deterioration of the slidability of the guide wire due to the extension of the inner tube 15.
  • the inner tube 15 has a reinforcing portion 15a having increased strength in a range that is connected at least by the connecting portion 52 in the axial direction, the inner tube 15 is connected by the connecting portion 52 when the balloon 30 is expanded. Even if the wire is pulled outward, it is possible to prevent deterioration of the slidability of the guide wire due to a decrease in strength of the portion.
  • the balloon catheter according to the above-described embodiment is an over-the-wire type, but may be a rapid exchange type.
  • the configuration of the invention according to the above embodiment is given as a preferred example, and the embodiment of the present invention is not limited to this. That is, various changes can be made within a range where the same effects as those of the present invention are achieved.
  • the connecting portion the example in which the shape of the end portion on the base end side is a smooth curved shape is given as an example, but the shape may be a triangle or a square.

Abstract

L'invention concerne un cathéter à ballonnet présentant de bonnes caractéristiques de remballage obtenues sans montage d'un élément extérieur à partir de l'extérieur du ballonnet. Ce cathéter à ballonnet possède un long corps de cathéter 11 et un ballonnet 30 qui est disposé sur le côté distal du corps de cathéter 11 et qui peut être gonflé et dégonflé. Le corps de cathéter 11 présente un tube extérieur creux 14 et un tube intérieur creux 15 qui est disposé à l'intérieur du tube extérieur. Lorsqu'il se trouve à l'état dégonflé, le ballonnet 30 est plié de façon à présenter : une section de contact 36 qui est en contact avec le tube intérieur 15; et une section de lame 37 qui fait saillie radialement à partir de la section de contact 36. Le ballonnet 30 possède une section de raccordement 40 au niveau de la section de contact 36, cette section de raccordement 40 étant reliée au corps de cathéter 11.
PCT/JP2015/084749 2015-01-26 2015-12-11 Cathéter à ballonnet WO2016121244A1 (fr)

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JP2016571804A JP6749847B2 (ja) 2015-01-26 2015-12-11 バルーンカテーテル
US15/653,078 US10617856B2 (en) 2015-01-26 2017-07-18 Balloon catheter

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GB2601761A (en) * 2020-12-08 2022-06-15 Ridgeback Tech Ltd Balloon catheters
WO2024035779A1 (fr) * 2022-08-12 2024-02-15 Boston Scientific Scimed, Inc. Ballonnet médical segmenté

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JPH05269207A (ja) * 1992-02-07 1993-10-19 Interventional Technol Inc 萎み可能折り畳み血管形成バルーン
US7887557B2 (en) * 2003-08-14 2011-02-15 Boston Scientific Scimed, Inc. Catheter having a cutting balloon including multiple cavities or multiple channels

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US10617856B2 (en) 2020-04-14
JP6749847B2 (ja) 2020-09-02
JPWO2016121244A1 (ja) 2017-11-02
US20170312487A1 (en) 2017-11-02

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